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RegisterFDA: AUC0–72 [Regulatives / Guidelines]
Dear Helmut,
Thank you so much for your explanation.
Can we use our pilot study data (CV % for partial AUC from pilot study) to support truncated design in pivotal study.
Regards
Thank you so much for your explanation.
❝ #2 is strange. Where would one get the X and Y from?
Can we use our pilot study data (CV % for partial AUC from pilot study) to support truncated design in pivotal study.
Regards
Complete thread:
- truncated design Mahesh M 2015-12-29 11:21 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FDA: AUC0–72 Helmut 2015-12-29 13:12
- FDA: AUC0–72Mahesh M 2015-12-29 13:51
- FDA: crystal ball Helmut 2015-12-29 15:43
- FDA: crystal ball Averroes 2016-05-27 00:01
- FDA: crystal ball Helmut 2015-12-29 15:43
- FDA: AUC0–72Mahesh M 2015-12-29 13:51
- FDA: AUC0–72 Helmut 2015-12-29 13:12
Ing. Helmut Schütz